Recall Z-0305-04 ยท DYG Catheter, Flow Directed
Abbott Laboratories HPD/ADD/GPRD
Pentalumen TD Thermodilution Catheter, Sterile
| Date | Jul 20, 2004 (initiated Nov 19, 2003) |
| Status | Terminated |
| Reason | Thermodilution catheters have a potential for ruptured lumens within the catheter. |
| Root cause | Other |
| Action | Consignees were notified by letter on 11/19/2003. |
| Quantity | 495 units |
| Distribution | AR,AZ, CA, FL, LA, MA, NC, OR, PA, TN, TX, UT, VA, WA. VA facilities in AR,AZ,FL and NC. No military or foreign distribution. |
| FDA record | Open on fda.gov |